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Completed Phase 2 Interventional Results available

Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)

ClinicalTrials.gov ID: NCT05686408

Public ClinicalTrials.gov record NCT05686408. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 11:20 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of TNX-601 ER monotherapy versus placebo in patients with Major Depressive Disorder (MDD).

Study identification

NCT ID
NCT05686408
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Tonix Pharmaceuticals, Inc.
Industry
Enrollment
132 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 1, 2023
Primary completion
Sep 28, 2023
Completion
Sep 28, 2023
Last update posted
Feb 16, 2025

2023

United States locations

U.S. sites
27
U.S. states
13
U.S. cities
27
Facility City State ZIP Site status
Preferred Research Partners Little Rock Arkansas 72211
Cenexel CIT - Bellflower Bellflower California 90706
Behavioral Research Specialists Glendale California 91206
Synergy Research Lemon Grove California 91945
Excell Research Oceanside California 92056
NCR Research Institute Orange California 92868
Cenexel CIT - Riverside Riverside California 92506
Artemis Institute for Clinical Research San Diego California 92103
Cenexel CNR - Sherman Oaks Sherman Oaks California 91403
Viking Clinical Research Temecula California 92951
Mountain View Clinical Research Denver Colorado 80209
CT Clinical Research Associates Cromwell Connecticut 06416
Gulfcoast Clinical Research Center Fort Myers Florida 33912
Clinical Neuroscience Solutions - Jacksonville Jacksonville Florida 32256
West Broward Outpatient Clinic Lauderhill Florida 33319
Segal Trials - North Miami Miami Lakes Florida 33016
Clinical Neuroscience Solutions - Orlando Orlando Florida 32801
Cenexel ACMR - Atlanta Atlanta Georgia 30331
Cenexel Research - Decatur Decatur Georgia 30030
Northwest Clinical Trials Boise Idaho 83704
Chicago Research Center Chicago Illinois 60634
Cenexel HRI - Berlin Berlin New Jersey 08009
Summit Research Network Portland Oregon 97210
Clinical Neuroscience Solutions - Memphis Memphis Tennessee 38119
Donald J. Garcia, Jr. Austin Texas 78737
Futuresearch Trials of Dallas Dallas Texas 75231
Core Clinical Research Everett Washington 98201

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05686408, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 16, 2025 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05686408 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →